Multi-centre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated With Parkinson's Disease
NCT ID: NCT01014858
Last Updated: 2017-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
64 participants
INTERVENTIONAL
2013-01-31
2014-09-30
Brief Summary
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To demonstrate the superiority of donepezil over placebo in improving patient and carer quality of life and to establish the cost-effectiveness of donepezil.
To determine the instrument most suitable for evaluating change in cognition in people with Parkinson's disease and mild dementia.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Donepezil
5mg of Donepezil for the first 8 weeks raising to 10mg thereafter if patient adjusted to 5mg dose. 10mg does continues for the remainder of the study.
Donepezil
5mg donepezil daily for first 8 weeks and then increased to 10mg daily for the remainder of the study.
Placebo
Patient commences medication to match appearance of 5mg donepezil for first 8 weeks then 10mg for the remainder of the study.
Donepezil
5mg donepezil daily for first 8 weeks and then increased to 10mg daily for the remainder of the study.
Interventions
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Donepezil
5mg donepezil daily for first 8 weeks and then increased to 10mg daily for the remainder of the study.
Eligibility Criteria
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Inclusion Criteria
2. People with mild dementia associated with PD, where the patient and/or their family have become aware of cognitive with or without behavioural symptoms that are causing functional impairment. "Dementia" will be defined according to recently published Movement Disorder Society Task Force criteria for dementia associated with Parkinson's Disease and "operationalised" using the Addenbrooke's Cognitive Examination (ACE-R). The ACE-R permits some description of the dementia profile and also quantifies global impairment. It is increasingly used by clinicians in the UK to identify demented subjects, is relatively quick to perform (15 minutes or so), requires no specific training and produces a total score (0-100), from which the MMSE (0-30) can also be extracted. Participants will have an ACE-R of 88 or less. If this criterion is met, subjects will be further assessed using the Mattis Dementia Rating Scale (DRS-2). An age- and education-corrected total DRS-2 score of less than 8 but greater than 4 (corresponding to between the 6th and 28th percentile) will be used to define "mild" dementia".
3. Community-living and a spouse, close relative or well established carer to accompany the subject to act as an informant.
4. Where relevant, women of child bearing potential must be using adequate contraception for duration of study.
Exclusion Criteria
2. People with such severe motor disability, or who are so impaired in their activities of daily living from other aspects of their PD, that it would interfere with cognitive and global assessments.
3. Severe current depressive episode. Low mood may impact upon accurate cognitive assessment and major depression is therefore listed as a feature which, when present, makes it impossible to reliably diagnose PDD in the Movement disorder Society Task Force PDD Criteria. This will be operationalised using the self-completed Beck Depression Inventory and a cut-off score of 13, as recommended by a recent Movement Disorder Society Task Force report. The BDI score is considered robust in the face of mild to moderate cognitive impairment.
4. Unstable significant medical co-morbidity.
5. Patient receiving an anticholinergic drug for control of parkinsonian motor symptoms.
6. Previous exposure to a cholinesterase inhibitor
7. Presence of a condition that is contraindicative to use of donepezil (including a clinically significant cardiac conduction defect found in patient history or from screening ECG); see SmPC (Appendix W) for details.
8. Allergy/hypersensitivity to excipients of donepezil or placebo
9. Patient receiving the N-methyl-d-aspartate antagonist memantine.
10. Previous neurosurgery for Parkinson's disease. This will apply to only a small minority of predominantly younger cases. The main reason for this exclusion relates to ongoing uncertainty over the potential confounding effects of deep brain stimulation upon both mood and cognition.
18 Years
ALL
No
Sponsors
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University of Newcastle Upon-Tyne
OTHER
University of Cambridge
OTHER
University of Manchester
OTHER
University of Birmingham
OTHER
Bangor University
OTHER
London School of Economics and Political Science
OTHER
University College, London
OTHER
Lancashire Care NHS Foundation Trust
NETWORK
Newcastle University
OTHER
King's College London
OTHER
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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David J Burn, Professor
Role: STUDY_CHAIR
Newcastle University
Roger A Barker, Dr
Role: STUDY_DIRECTOR
Cambridge University
Belinda Braithwaite, Mrs
Role: STUDY_DIRECTOR
lay person
Alistair Burns, Professor
Role: STUDY_DIRECTOR
School of Community Based Medicine, University of Manchester
Carl E Clarke, Professor
Role: STUDY_DIRECTOR
Clarke
Elaine McColl, Professor
Role: STUDY_DIRECTOR
University of Newcastle Upon-Tyne
John V Hindle, Dr
Role: STUDY_DIRECTOR
Llandudno Hospital & University of College Wales
Martin Knapp, Professor
Role: STUDY_DIRECTOR
London School of Economics and Political Science
Andrew J Lees, Professor
Role: STUDY_DIRECTOR
University College, London
Iracema Leroi, DR
Role: STUDY_DIRECTOR
Lancashire Care Trust, Royal Blackburn Hospital
Ian G McKeith, Professor
Role: STUDY_DIRECTOR
Newcastle University
John T O'Brien, Professor
Role: STUDY_DIRECTOR
Newcastle University
Keith Wheatley, Professor
Role: STUDY_DIRECTOR
Cancer Research UK Clinical Trials Unit, School of Cancer Sciences, University of Birmingham
Ian N Steen, Dr
Role: STUDY_DIRECTOR
University of Newcastle Upon-Tyne
Jennifer Wilkinson, Mrs
Role: STUDY_DIRECTOR
University of Newcastle Upon-Tyne
Sharon Erb, Mrs
Role: STUDY_DIRECTOR
University of Newcastle Upon-Tyne
Daniel Weintraub
Role: STUDY_DIRECTOR
Associate Professor of Psychiatry and Neurology, Perelman School of Medicine at the University of Pennsylvania
Lynn Rochester
Role: STUDY_DIRECTOR
Professor of Human Movement Science, Institute for Ageing and Health, Newcastle University
Locations
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Newcastle
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Royal United Hospital (RUH) Bath NHS
Bath, , United Kingdom
Sandwell and West Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Steps and Pines, Southmead Hospital
Bristol, , United Kingdom
Pennine Acute Hospitals NHS Trust
Bury, , United Kingdom
Cambridge Centre for Brain Repair
Cambridge, , United Kingdom
Dr Lakmali Sugathapala
Derby, , United Kingdom
Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust
Dorset, , United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
Dr Pippa Metcalf
Gloucester, , United Kingdom
Llandudno Hospital, Betsi Cadwaladr University Health Board & School of Medical Sciences
Llandudno, , United Kingdom
King's College Hospital NHS Foundtion Trust
London, , United Kingdom
Manchester Mental Health & Social Care NHS Trust
Manchester, , United Kingdom
Milton Keynes
Milton Keynes, , United Kingdom
Royal Gwent Hospital
Newport, , United Kingdom
North Tyneside General Hospital
Northumberland, , United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Plymouth Hospitals NHS Trust
Plymouth, , United Kingdom
Poole Hospital NHS Trust
Poole, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Dr Dhakam
Surrey, , United Kingdom
Countries
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Other Identifiers
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08/13/14
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
5137
Identifier Type: -
Identifier Source: org_study_id